Phase 2 Myeloma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 75 years old, of any gender
• People who are willing to take part and have signed an informed consent form (either themselves or through a legal guardian)
• People who have been diagnosed with multiple myeloma that has come back or stopped responding to treatment — specifically, where treatment containing bortezomib or lenalidomide did not work, or the disease got worse within 60 days of finishing the last treatment
• People who have one or more measurable signs of multiple myeloma, such as certain protein levels in the blood or urine, abnormal light chain levels, a detectable tumour, or a high proportion of myeloma cells in the bone marrow
• People whose myeloma cells have tested positive for two specific markers called BCMA and GPRC5D
• People who have not received certain chemotherapy treatments in the 4 weeks before the cell therapy, or certain antibody-based treatments in the 2 weeks before
• People with a general health/activity score (called ECOG) of 0, 1, or 2 — meaning they are able to carry out basic daily activities
• People who are medically able to undergo a blood cell collection procedure (apheresis)
• People with an expected survival of at least 12 weeks
• Women of childbearing age who have had a negative pregnancy test within 7 days before the cell therapy and who are not breastfeeding; all participants of childbearing age (male or female) must use effective contraception throughout the study

Who may not be able to join:

• People with a known allergy to any ingredient in the cell therapy product
• People with certain abnormal blood or organ function results, including liver enzyme levels, bilirubin, creatinine, haemoglobin, neutrophil count, or platelet count outside of specified ranges (confirm with trial site)
• People with moderate to severe heart failure (classified as Grade III or IV by heart disease standards), or a heart pumping function (LVEF) below 50% on ultrasound
• People with abnormal lung function or blood oxygen levels below 92% when breathing normal room air
• People who have had a heart attack, heart procedure (such as stenting or angioplasty), unstable chest pain, or other serious heart conditions within the past 12 months
• People with severe, uncontrolled high blood pressure (Grade 3) that medication has not brought under control
• People with a prolonged QT interval on a heart tracing (ECG), or a history of serious heart rhythm problems
• People with a history of serious head injury, loss of consciousness, epilepsy, or significant stroke or brain bleeding
• People who need to take anticoagulant (blood-thinning) medication, other than aspirin
• People who need urgent treatment because their cancer is advancing rapidly or is pressing on the spinal cord
• People with cancer that has spread to the brain or central nervous system, or who have related symptoms such as nerve problems or spinal cord compression
• People with serious additional health conditions that the investigators believe would increase risk or interfere with the study, such as liver cirrhosis or recent major injury
• People who have previously had an allogeneic (donor) stem cell transplant
• People diagnosed with plasma cell leukaemia
• People who have been taking more than 5 mg per day of prednisone (or an equivalent steroid) within 2 weeks before the CAR-T cell infusion or before the blood collection procedure
• People with autoimmune diseases, immune deficiency conditions, or anyone who needs immune-suppressing medication
• People who currently have an uncontrolled active infection
• People who have received a live vaccine within 4 weeks before enrolling
• People with HIV, Hepatitis B (HBV), Hepatitis C (HCV), or syphilis infections, including HBV carriers
• People with a history of alcoholism, drug misuse, or mental illness
• People who have taken part in another clinical trial within the 3 months before joining this study
• People whom the investigators consider unsuitable for the study for any other reason

Important: Always verify eligibility with the trial site directly before applying.